Clinical trial to define the optimal duration of antibiotic treatment for patients with certain infections that produce the passing of bacteria into the bloodstream.

Phase 1

Conditions: Adult patients with bloodstream infections produced by Enterobacteriaceae.
MedDRA version: 16.1Level: PTClassification code 10060945Term: Bacterial infectionSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2013-002148-95-ES

Lead Sponsor: Fundación Pública Andaluza para la Gestión en Salud de Sevilla (FISEVI)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Adult patients (equal or over 18 year-old).
2. Bloodstream infections produced Enterobacteriaceae, either primary or secondary.
3. The source of the bacteremia should be properly controlled or is expected to be properly controlled in the next 24 hours (i.e. bacteremia produced by infected vascular catheter, abscess, obstruction of the biliar or urinary tract, if the source of bacteremia has been or is expected to be properly drained or removed in the next 24 hours).
4. Patient should be able to understand the objectives and procedures of the clinical trial, and signs the informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

1. Pregnancy.
2. Neutropenia post-chemotherapy that is expected to persist more than 7 days.
3. Uncontrolled source of bacteremia at inclusion or in the following 24 hours. The source will be considered as uncontrolled if the bacteremia is secondary to a suppurative infection potentially removable, if no action has been taken to erradicate it: bacteremia related to vascular catheter not removed; cholangitis secondary to not derived obstruction of the billiary tract; deep abscess not drained; piohydronephrosis without derivation of the urinary tract.
4. Bacteremia due to infective endocarditis, bone and joint infections, or neurosurgical infections, which may requiere prolongued antimicrobial therapy.
5. Bacteremia due to Enterobacteriacea resistant to carbepenems.
6. Polymicrobial bacteremia including microorganisms different to Enterobacteriaceae.
7. Patients with no expectations of survival in the next 48 hours at inclusion.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To prove that a 7-day course of antibiotic therapy is more efficient than a 14-day course when treating Enterobacteriaceae bacteremia, in terms of number of days of antibiotic treatment at the end of follow-up.;Secondary Objective: 1. To prove that a 7-day course of antibiotic therapy is as safe as a 14-day course in terms of:<br>- Clinical and microbiological cure;<br>- Rate of adverse effects, including: adverse reactions to drugs, superinfections by resistant bacteria or diarrhea by Clostridium difficile.<br><br>2. To analyze the utility of procalcitonin as a biomarker to decide the end of the antimicrobial treatment for Enterobacteriaceae bacteremia.;Primary end point(s): Days of antimicrobial treatment.;Timepoint(s) of evaluation of this end point: Day +28 after the initiation of aproppriate antimicrobial treatment.

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Day +28 after the initiation of aproppriate antimicrobial treatment.;Secondary end point(s): Clinical and microbiological cure, mortality, adverse reactions related to antimicrobial treatment, relapse of the infection, superinfections.